imetelstat sodium · Geron · NDA 217779
Rytelo
Earliest generic entry, as listed · earliest of 2 marketed strengths
16 Jun 2039
Blocked by patent: US 12171778. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12171778 | use U-3956 | 16 Jun 2039 |
| US 12442000 | use U-3956 | 15 Mar 2033 |
| US 9375485 | use U-3956 | 15 Mar 2033 |
| US 7494982 | substance, product | 27 Dec 2026 |
Exclusivities · 1 unexpired
| ODE-482 | orphan drug (7 years) | 6 Jun 2031 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217779 · 001 · RLD | powder, intravenous | EQ 47MG BASE/VIAL | 16 Jun 2039 |
| 217779 · 002 · RLD | powder, intravenous | EQ 188MG BASE/VIAL | 16 Jun 2039 |
Expired or delisted (2)
- US 9388415 · use U-3956 · 9 Sep 2026
- US 9388416 · use U-3956 · 9 Sep 2026